Download - Mepilex - Molnlycke
Manufacturer / Fabricant Mölnlycke Health Care AB Gamlestadsvägen 3C, Box 13080
SE-402 52 Göteborg, Sweden www.molnlycke.com
Mepilex® Ag
Mepilex® Heel Ag
25°C / 77°F
Upper temperature limit Limite de température supérieure Canada 1-800-494-5134
Medical Device
Medizinprodukt
Dispositif médical
Dispositivo médico
Medisch hulpmiddel
Medicinsk utrustning
Dispositivo medico
Lääkinnällinen laite
Dispositivo médico
Medicinske anordninger
Ιατρική συσκευή
Urządzenie medyczne
Lékařský přístroj
Orvosi eszköz
Medisinsk utstyr
Medicinska naprava
Медицинско изделие
Dispozitiv medical
Lekársky prístroj
Tıbbi Cihaz
Medicinos prietaisas
Medicīniska ierīce
Meditsiiniseade
Медицинское изделие
Medicinski uređaj
Medicinsko sredstvo
Medicinski uređaj
جهاز طبي
www.molnlycke.com/symbols
Do not use if package is damaged
Bei beschädigter Verp. verwerfen
Ne pas utiliser si l’emballage est endommagé
No utilizar si el envase está dañado
Niet gebruiken indien verpakking beschadigd is
Skall inte användas om förpackningen är skadad
Non utilizzare se la confezione è danneggiata
Älä käytä jos pakkaus vaurioitunut
Não usar se embalagem danificada
Brug ikke, hvis pakken er beskadiget
Μην το χρησιμοποιήσετε αν η συσκευασία είναι κατεστραμμένη
Nie stosować, jeśli opakowanie jest uszkodzone
Nepoužívejte, je-li obal poškozen
Ne használja, ha a csomagolás sérült
Må ikke brukes hvis forpakningen er skadet
Ne uporabite, če je ovoj poškodovan
Не използвайте, ако опаковката е увредена
Nu utilizaţi dacă ambalajul e deteriorat
Nepoužívajte, ak je obal poškodený
Ambalaj hasarlıysa kullanmayın
Nenaudoti, jei pakuotė pažeista
Nelietot, ja iepakojums ir bojāts
Kahjustatud pakendi korral mitte kasutada
Не использ., если упак. поврежд.
Ne koristiti ako je pakiranje oštećeno
Ne koristiti ako je omot oštećen
Nemojte koristiti ako je pakovanje oštećeno
For low exuding wounds
Für schwach exsudierende Wunden
Pour les plaies faiblement exsudatives
Para heridas con poco exudado
Voor licht exsuderende wonden
För svagt vätskande sår
Per lesioni scarsamente essudanti
Vähän erittäville haavoille
Para feridas com exsudado reduzido
Til let væskende sår
Για τραύματα ελαφρού εξιδρώματος
Rany z małym wysiękiem
Na slabě exsudující rány
For moderately exuding wounds
Für mäßig exsudierende Wunden
Pour les plaies modéré-ment exsudatives
Para heridas con exudado moderado
Voor matig exsuderende wonden
För måttligt vätskande sår
Per ferite moderata-mente essudanti
Kohtalaisesti erittäville haavoille
Para feridas com exsudado moderado
Til moderat væskende sår
Για τραύματα ήπιου εξιδρώματος
Rany z umiarkowanym wysiękiem
Na středně exsudující rány
For highly exuding wounds
Für stark exsudierende Wunden
Pour les plaies hautement exsudatives
Para heridas con mucho exudado
Voor sterk exsuderende wonden
För kraftigt vätskande sår
Per lesioni altamente essudanti
Runsaasti erittäville haavoille
Para feridas com exsudado intenso
Til kraftigt væskende sår
Για τραύματα έντονου εξιδρώματος
Rany z dużym wysiękiem
Na vysoce exsudující rány
Enyhén váladékozó Közepesen váladékozó Erősen váladékozó sebekhez sebekhez sebekhez
Brukes på lett Brukes på moderat Brukes på sterkt væskende sår væskende sår væskende sår
Za rane z malo izcedka Za rane z zmerno Za rane z veliko količino količino izcedka izcedka
За слабо ексудиращи За умерено За силно ексудиращи рани ексудиращи рани рани
Pentru răni care Pentru răni care Pentru răni care exsudează uşor exsudează moderat exsudează abundent
Pre mierne mokvajúce Pre stredne mokvajúce Pre silne mokvajúce rany rany rany
Hafif eksudasyonlu Orta eksudasyonlu Çok eksudasyonlu yaralar için yaralar için yaralar için
Mažai eksuduojančioms Vidutiniškai eksuduo- Stipriai eksuduojan-žaizdoms jančioms žaizdoms čioms žaizdoms
Brūcēm ar zemu Brūcēm ar mērenu Brūcēm ar augstu eksudācijas pakāpi eksudācijas pakāpi eksudācijas pakāpi
Vähese eritusega Keskmise eritusega Rohke eritisega haavadele haavadele haavadele
Для ран с низкой Для ран с умеренной Для ран с обильной экссудацией экссудацией экссудацией
Za slabo vlažeće rane Za umjereno vlažeće Za iznimno vlažeće rane rane
Za rane sa blagom Za rane sa umerenom Za rane sa izraženom eksudacijom eksudacijom eksudacijom
تازارفإلا ةليلق حورجلل تازارفإلا ةطسوتم حورجلل تازارفإلا ةريثك حورجلل
Mepilex® Ag Antimicrobial soft silicone foam dressing
Product description Mepilex Ag consists of a Safetac® wound contact layer, a flexible absorbent pad of grey polyurethane foam containing silver sulphate and coloured by activated carbon and a breathable and water proof film. Safetac® is a proprietary adhesive technology developed by Mölnlycke that minimises pain to patients and trauma to intact skin or wounds. Mepilex Ag is a highly conformable dressing that absorbs exudate and maintains a moist wound environment. Mepilex Ag contains silver sulphate that releases silver ions to create an effective bacterial barrier and inactivates a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of microorganisms, Mepilex Ag may also reduce odour. Mepilex Ag has also been shown to inactivate wound related pathogens, up to 7 days in vitro.
Dressing material content: polyurethane, silicone, silver sulphate which equals to 1.2 mg/cm2 silver
Indications for use Mepilex Ag is an antimicrobial soft silicone foam dressing that is designed for the management of low to moderately exuding leg and foot ulcers, pressure ulcers and partial thickness burns. Mepilex Ag may be used on infected wounds as part of a treatment regimen under supervision of a qualified health care professional. Mepilex Ag can be used under compression bandaging.
Precautions • Do not use Mepilex Ag on patient and/or user with known hypersensitivity to the
ingoing materials/components of the product. • Clinicians/healthcare professionals should be aware that there are very limited
data on prolonged and repeated use of silver containing dressings, particularly in children and neonates.
• Frequent or prolonged use of this product may result in transient or permanent discoloration of skin.
• Do not reuse. If reused performance of the product may deteriorate, cross contamination may occur.
• Sterile. Do not use if sterile barrier is damaged or opened prior to use. Do not re-sterilise.
Instructions for use Mepilex Ag should be used by or under the supervision of a qualified health care professional.
Note that local hygiene procedures should be followed prior to and following the dressing change.
1. Cleanse the wound with saline solution or water according to standard clinical practice.
2. Dry the surrounding skin thoroughly. 3. Select appropriate dressing size. For best clinical outcomes, ensure that the
product covers the wound bed and overlaps the wound edges. 4. Cut to appropriate size (if needed). Remove the release films and apply the
adherent side to the wound. Do not stretch. 5. When necessary, fixate Mepilex Ag with a bandage or other fixation.
Each Mepilex Ag dressing may be left in place for 7 days depending on the condition of the wound and surrounding skin, or as indicated by accepted clinical practice. A change in dressing regimen can result in an initial increased level of exudates, which temporarily may require an increased change frequency. Mepilex Ag is intended for short-term use up to 4 weeks. For long-term use, a clinical assessment by a physician is recommended. In case of clinical infection Mepilex Ag does not replace the need for systemic or other adequate infection treatment. The interaction of Mepilex Ag together with cleansing agents, oxidising agents such as hypochlorite solutions/hydrogen peroxide and topical treatments has not been demonstrated. Prior to commencing radiation therapy, remove Mepilex Ag if product is present in the treatment area. A new dressing can be applied following treatment. Avoid contact with electrodes or conductive gels during electronic measurements, e.g. electrocardiograms (ECG) and electroencephalograms (EEG).
Special storage conditions and handling conditions Mepilex Ag should be stored in dry conditions below 25°C/77°F and protected from direct sunlight. Note that any colour variances in Mepilex Ag do not affect product performance or safety. Disposal should be handled according to local environmental procedures.
Other information For EU-customers, for further information on the safety and clinical performance of Mepilex Ag please refer to the ‘Summary of Safety and Clinical Performance for Mepilex Ag’. You can access the document on molnlycke.com. In the future the document will also be published in the European Database on Medical Devices, EUDAMED.
If any serious incident has occurred in relation to the use of Mepilex Ag, it should be reported to Mölnlycke Health Care.
Mepilex and Safetac are registered trademarks of Mölnlycke Health Care AB.
Master PD-550227 rev02 Revised 2019-05
Made in Finland PD-563109 rev00